An Arizona company, HSRx Group, claims it has an over-the-counter (OTC) topical analgesic that is superior to a competitor’s joint relief tablet in relieving joint pain and improving range of motion. But the release contains no evidence from the “independent clinical study” it references in the headline and text.
No study authors are named in the news release, and contrary to a statement in the release, no further information on the study is available on the company website. We reached out to the company to ask for a copy of the research but received no reply.
An online search of Osteo-Rx, the product that’s the subject of the release, led to several sites selling the product in the supplement category, not as an OTC drug. Unlike approved OTC drugs, supplements are not regulated by the Food and Drug Administration. Adding to the confusion, the news release calls the product a topical analgesic, which indicates it’s a cream, but sites selling Osteo-RX online only have it pictured in tablet form.
Osteoarthritis is prevalent among those past middle age. With more and more baby boomers hitting their senior years, joint pain is a growing concern. OTC interventions for joint pain — solutions that work — are welcome and important. But in this release, claims suggest scientific credibility but they do not represent genuinely credible scientific research. Many readers may be fooled by a sentence in the release claiming that the drug’s benefit has been “proven by independent clinical research.” We looked behind the curtain and asked — where is the study? Who are the authors? When was it published? What does it prove?
People in pain from arthritis deserve the real evidence — not empty and misleading PR releases.
The release does not contain any cost information of interest to people suffering from joint pain. The chief financial officer, Frank Parise, mentions money only in relation to his company’s fundraising efforts:
“We are actively seeking the best-suited licensees having resources and marketing expertise to maximize sales for each of our products in the U.S. and globally.”
A bottle of 120 tablets of Osteo-Rx sells for $19.99 on the company’s website.
The release provides incomplete and potentially misleading information regarding benefits. The benefits are never given in specific numbers but only as X times the amount the other drug provided. Examples:
“After 48 hours, the average pain reduction for OsteoRx™ users was nearly three times greater than for patients using the competing brand. At seven days, average pain reduction was more than three times greater than the competition. After 14 days of treatment, average pain reduction was more than twice as large as the competition.”
“After just 24 hours, patients using OsteoRx™ experienced an average improvement in range of motion that was more than twice as large as the competition. At 72 hours, OsteoRx™ results were nearly five and a half times better. After 14 days of treatment, the average improvement was still nearly twice as large as the competition.”
That’s like claiming if the other drug provided a smidgen, this drug provided 2 smidgens. Not very good evidence.
The release does not discuss any potential harms of the topical cream or tablet — or whatever it truly is.
The release describes the study as “randomized, double-blind, placebo-controlled study” that enrolled 60 patients with mild to moderate osteoarthritis of the knee. Measurements in the level of pain and range of motion in the affected knee were recorded over a 14-day period for each patient.
But just as noted above under the benefits criterion, the evidence from the trial is described in very vague terms, with no hard numbers describing the outcome. In the absence of any study authors or link to a study publication, or even self-published research on the company’s website, the reader cannot find any evidence backing up the claims made in the release.
We aren’t told who sponsored the referenced clinical trial, just that it was performed by an “independent clinical research organization.” The release should have provided information about where the trial was conducted, by whom, and whether there was any conflict if the study was funded by the manufacturer of the product.
The release compares two competing commercial products for arthritis pain, but does not provide the wider context that pain treatment encompasses many therapies including drugs, gentle exercise, weight loss, acupuncture and many others.
The point of the release appears to be an advertisement for a product that is already available. The supplement was readily found online.
The release suggests newsworthiness by stating the subject product outperformed another. We are not told the ingredients for either product so it’s impossible to judge the novelty of this combination with the limited information provided.
The headline is unjustifiable. It refers to a “clinical research study” which is never identified or referenced.
Due to the absence of the clinical study, the claims of pain relief and increased range of motion are also unjustifiable.
Systematic, Criteria-Driven
Why it’s time that the US National Library of Medicine added OVERDIAGNOSIS to its medical subject headings. By Steve Woloshin & Barry Kramer, who’ve been teaching us about this for years. https://www.bmj.com/content/375/bmj.n2854
This thread on #Gates funded pandemic reporting is worth reading
cc @garyschwitzer @DavidCallahanIP @thackerpd @natashaloder @donatopmancini @jamie_love @HansGutbrod @transparify @HAITim @deb_cohen @OSFHealth @SteveJGoodrich @diarmaidmcd @thackerpd @HealthWatchUK @YNatsis https://twitter.com/TimothyWSchwab/status/1448321233326592007
Great advice for reporters and biomedical PR folk via the @AHCJ blog and @garyschwitzer: https://healthjournalism.org/blog/2021/09/elizabeth-holmes-trial-a-reminder-to-never-fall-for-the-hype/
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